Overdose

No cases of Soliris overdose have been reported during clinical studies.

What is the most important information i should know about eculizumab (soliris)?

Eculizumab is used to prevent the breakdown of red blood cells in people with paroxysmal nocturnal hemoglobinemia (PNH).

You should not use this medication if you have bacterial meningitis or if you have not been vaccinated against meningitis. Tell your doctor if you have a fever or any type of infection.

Eculizumab affects your immune system, and using this medication may increase your risk of serious infection such as meningitis. You must be vaccinated against meningococcal infection at least 2 weeks before you start treatment with eculizumab. Even if you have been vaccinated in the past, you may need a booster dose.

Seek emergency medical attention or call your doctor right away if you notice any of these symptoms of meningitis: headache and fever with nausea or vomiting, high fever (103 degrees or higher), body aches, flu symptoms, confusion, increased sensitivity to light, stiffness in your neck or back.

With your medication you will receive a Patient Safety Card listing the symptoms of meningitis. Carry this card with you at all times.

Do not stop using eculizumab without first talking to your doctor. Stopping or interrupting your treatment could cause sudden and serious effects on your red blood cells.

What should i discuss with my health care provider before taking eculizumab (soliris)?

Eculizumab affects your immune system, and using this medication may increase your risk of serious infection such as meningitis.

You must be vaccinated against meningococcal infection at least 2 weeks before you start treatment with eculizumab. Even if you have been vaccinated in the past, you may need a booster dose.

It is best to stay current on all of your vaccinations while you are using eculizumab, and your doctor may recommend other vaccines before or during treatment.

Children being treated with eculizumab may also need to be vaccinated against influenza or pneumonia before treatment begins.

You should not use this medication if you are allergic to eculizumab, if you have bacterial meningitis, or if you have not been vaccinated against meningitis.

To make sure you can safely use eculizumab, tell your doctor if you have a fever or any type of infection.

FDA pregnancy category C. It is not known whether eculizumab will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether eculizumab passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Eculizumab is available only under a special program called Soliris REMS. You must be registered in the program and sign documents stating that you understand the risks and benefits of taking this medication.

What is the most important information I should know about eculizumab?

You should not use this medicine if you have bacterial meningitis or if you have not been vaccinated against meningitis. Using eculizumab can increase your risk of getting meningitis. You must be vaccinated against meningococcal infection at least 2 weeks before treatment with eculizumab. If you have been vaccinated in the past, you may need a booster dose.

Seek emergency medical attention or call your doctor right away if you have symptoms of meningitis: headache and fever with nausea or vomiting, skin rash, body aches, flu symptoms, confusion, sensitivity to light, stiffness in your neck or back.

You will receive a card listing the symptoms of meningococcal infection, to carry with you at all times. During treatment with eculizumab and for at least 3 months after your last dose, make sure any doctor who treats you knows that you are using this medicine.

Do not stop using eculizumab without first talking to your doctor. Stopping or interrupting your treatment could cause sudden and serious effects on your red blood cells.

How is eculizumab given?

In adults, eculizumab is usually given once a week for 5 weeks, and then once every 2 weeks thereafter. This schedule may be different for a child or teenager. Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

If a child is using this medicine, tell your doctor if the child has any changes in weight. Eculizumab doses are based on age and weight in children, and any changes may affect your child's dose.

Eculizumab is injected into a vein through an IV. You may be shown how to use an IV at home. Do not give yourself this medicine if you do not understand how to use the injection and properly dispose of needles, IV tubing, and other items used.

You should be watched closely for at least 1 hour after each infusion, to make sure you do not have an allergic reaction to the medication.

Eculizumab must be mixed in an IV bag with a liquid (diluent) before injecting it. Prepare your dose only when you are ready to give an injection. Do not shake the medication bottle or you may ruin the medicine. If you are using the injections at home, be sure you understand how to properly mix and store the medicine. Do not use if the medicine has changed colors or has particles in it. Call your pharmacist for new medicine.

The medicine may be cold after you mix it. To reduce discomfort during your injection, allow the mixed medicine to reach room temperature before using. Never warm the medicine in hot water or a microwave. You may store the mixture at room temperature but you must use it within 24 hours or throw the mixture away.

Eculizumab must be given slowly, and the infusion can take at least 35 minutes to complete in adults, or up to 4 hours in children.

You may have an infusion reaction when the medicine is injected into the vein. If this happens, you may need to slow down the speed of your IV infusion, but the infusion should not take more than 2 hours to complete in an adult, or 4 hours in a child. A caregiver or family member should then watch you for at least 1 hour after your injection to make sure you have no further side effects.

Do not stop using eculizumab without first talking to your doctor. Stopping or interrupting your treatment could cause sudden and serious effects on your red blood cells.

If you stop using eculizumab for any reason, your blood may need to be tested on a regular basis for 8 to 12 weeks. Do not miss any follow-up visits to your doctor.

During treatment with eculizumab and for at least 3 months after your last dose, make sure any doctor who treats you knows that you are using this medicine.

Store unopened vials in their original carton in the refrigerator. Protect from light and do not freeze. Throw away any unused vials after the expiration date on the label has passed.

Each single-use vial (bottle) of this medicine is for one use only. Throw away after one use, even if there is still some medicine left in it after injecting your dose.

Use a disposable needle and syringe only once. Follow any state or local laws about throwing away used needles and syringes. Use a puncture-proof "sharps" disposal container (ask your pharmacist where to get one and how to throw it away). Keep this container out of the reach of children and pets.

Importance of immunization against meningococcal infections at least 2 weeks prior to initiation of therapy and revaccination or booster doses according to current guidelines while on therapy.1 6 21 Advise patients that vaccination may not prevent infection; importance of informing clinician immediately if manifestations of meningococcal infection (headache with nausea, vomiting, fever, stiff neck or back; temperature ≥39.4°C; fever with rash; confusion; severe muscle aches with flu-like symptoms; light sensitivity) develop.1 21

Advise parents/caregivers of children with aHUS that their child should be vaccinated against S. pneumoniae and Hib infections prior to initiation of therapy.1

Importance of informing patients with PNH that discontinuance of therapy may cause sudden hemolysis; importance of monitoring for hemolysis for at least 8 weeks following treatment discontinuance.1 21

Importance of informing patients with aHUS that discontinuance of therapy may result in a worsening of disease symptoms or problems related to thrombotic microangiopathy.1

Importance of patients carrying a patient safety card (describing symptoms requiring immediate medical attention) at all times during treatment and for 3 months following discontinuance of therapy because the risk of meningococcal infection may persist for weeks after the last dose is given.1 21

Importance of women informing their clinicians if they are or plan to become pregnant or plan to breast-feed.1 21

Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as concomitant illnesses.1 21

Importance of informing patients of other important precautionary information.1 21 (See Cautions.)

Uses of Eculizumab

It is used to treat a blood disease called paroxysmal nocturnal hemoglobinuria (PNH).

It is used to treat a blood and kidney disease called atypical hemolytic uremic syndrome (aHUS).

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.

Signs of infection like fever, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or wound that will not heal.

Signs of a meningococcal infection like very bad headache with or without upset stomach, throwing up, fever, or stiff neck or back; change in thinking clearly and with logic; high fever; fever with a rash; if light bothers the eyes; or very bad muscle aches or pain with or without flu-like signs.

Signs of low potassium levels like muscle pain or weakness, muscle cramps, or a heartbeat that does not feel normal.

Chest pain.

Not able to pass urine or change in how much urine is passed.

A fast heartbeat.

Very bad dizziness or passing out.

Very bad headache.

Swelling in the arms or legs.

Feeling very tired or weak.

Dosing Pediatric

Note: Patients must receive meningococcal vaccine at least 2 weeks prior to treatment initiation; revaccinate according to current guidelines. Administer eculizumab at the recommended time interval or within 2 days of the interval.

Administration

IV: Allow to reach room temperature prior to administration. Infuse over 35 minutes in adults and over 1 to 4 hours in pediatric patients; do not administer as an IV push or bolus. Decrease infusion rate or discontinue for infusion reactions; do not exceed a maximum 2-hour duration of infusion in adults. Monitor for at least 1 hour following completion of infusion (for signs/symptoms of infusion reaction).

aHUS: Signs/symptoms of thrombotic microangiopathy (TMA) complications (monitor for at least 12 weeks after treatment discontinuation), including angina, dyspnea, mental status changes, seizure, or thrombosis; occurrence of two or repeated measurement of any one of the following: Serum creatinine elevation (≥25% from baseline or nadir), serum LDH elevation (≥25% from baseline or nadir), thrombocytopenia (platelet decrease by ≥25% compared to baseline or peak).

Pregnancy Risk Factor C Pregnancy Considerations

Adverse events were observed in animal reproduction studies. Eculizumab crosses the placenta and can be detected in cord blood. Pregnant women with PNH and their fetuses have high rates of morbidity and mortality during pregnancy and the postpartum period. Treatment of PNH with eculizumab has been shown to increase fetal survival and decrease maternal complications (Kelly 2015). Use of eculizumab for the treatment of a HUS in pregnancy has also been described (Ardissino 2013).

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

For the Consumer

Applies to eculizumab: intravenous solution

Along with its needed effects, eculizumab may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking eculizumab:

More common

Back pain

black, tarry stools

bladder pain

bloody or cloudy urine

blurred vision

burning or stinging of the skin

chest pain

cough

difficult, burning, or painful urination

difficulty with moving

dizziness

fever

headache

joint pain

lower back or side pain

muscle ache, cramp, pain, stiffness

nausea

nervousness

pain or tenderness around the eyes and cheekbones

painful cold sores or blisters on the lips, nose, eyes, or genitals

pale skin

pounding in the ears

slow or fast heartbeat

sneezing

sore throat

sores, ulcers, or white spots on lips or in the mouth

stuffy or runny nose

swollen glands or joints

tightness of the chest

troubled breathing with or without exertion

unusual bleeding or bruising

unusual tiredness or weakness

Less common

Chills

diarrhea

general feeling of discomfort or illness

loss of appetite

shivering

sweating

trouble sleeping

vomiting

Some side effects of eculizumab may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

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